ISO 13485

ISO 13485 is the standard for a Quality Management System for the design and manufacture of Medical-Devices.

ISO 13485 Certification is worldwide ISO standard who required in some nations, and in the U.S. the FDA has proposed a standard which would harmonize united states (U.S.) FDA 21 CFR 820 with ISO 13485 standard, making ISO 13485 standard the FDA's mandatory QMS for Medical Devices (the standard is required to be delivered in 2019). Meanwhile, the medical-device industry can depend on AAMI TIR102:2019, which is a bi-directional mapping tool that was delivered on August 30, 2019.

for more information visit SIS Certifications Pvt. Ltd. Website.

ISO 13485-2003 is a modification of ISO9001:2000 for the medical device industry.

Similar standards are:

* ISO/TS 16949 for the automotive

* AS9100 for the aeronautical industry * TL 9000 for the telecommunications industry These standards are based on the ISO 9001 with specific extra requirements of the industry added

ISO 13485 Certification is the international standard for quality management most widely used for the medical devices industry. Issued by the International Organization for Standardization (ISO).

Advantages of ISO 13485 Certification

Customer satisfaction

Reduced operating costs

Improved stakeholder relationships

Legal compliance

Improved risk management

Proven business credentials

Ability to win more business

http://learn.uci.edu/media/AR01/06011/ISO_13485_2003.pdf